Study Details

A paediatric, open, follow up study with Modigraf examining safety and efficacy in de novo allograft recipients

Terminated/Withdrawn
The study has stopped early and will not start again. Participants were not enrolled (for withdrawn studies), however if participants were enrolled, they are no longer being examined or treated.

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01371344

Astellas Study ID

The unique identification code given by the study sponsor.

F506-CL-0404

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2009-012259-21

Condition

Heart Transplants, Kidney Transplants, Liver Transplants

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

0 years - 12 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2011 - Apr 2017

Masking

None (Open Label)

Enrollment number

47

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site FR60 Groupement Hospitalier EST

Bron, France, 69677

Site ES23 Hospital Universitario La Paz

Madrid, Spain, 28046

Site ES20 Hospital Universitario La Paz

Madrid, Spain, 28046

Site FR61 Hopital Robert Debre

Paris Cedex 19, France, 75945

Site GB11 Great Ormond Street Hospital

London, United Kingdom, WC1N3JH

Site GB14 Alder Hey Children Hospital

Liverpool, United Kingdom, L12 2AP

Site ES22 H.U. Gregorio Maranon

Madrid, Spain, 28007

Site BE41 U.Z. Leuven

Leuven, Belgium, 3000

Site DE30 Universitätsklin Heidelberg

Heidelberg, Germany, 69120

Site ES21 Hospital Universitario La Paz

Madrid, Spain, 28046

Site BE40 Clinique Univ. Saint Luc

Brussels, Belgium, 1200

Site GB13 Cent. Manchester Uni. Hospital

Manchester, United Kingdom, M13 9WL

Site DE31 Kliniken der Medizinischen Hoc

Hannover, Germany, 30625

Site GB10 Birmingham Children's Hospital

Birmingham, United Kingdom, B4 6NH

Site PL50 Centrum Zdrowia Dziecka

Warsaw, Poland, 04-730